A Safety Study in Patients With Advanced Prostate Cancer Treated With FIRMAGON

NCT ID: NCT01234350

Last Updated: 2019-06-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1493 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2018-03-27

Brief Summary

This study is a large observational study, set-up to observe how long-term treatment with FIRMAGON (hormone regulator) compare to other treatments in regards to cardiovascular events, changes in bone density, changes in blood sugar levels or liver enzyme levels in subjects with prostate cancer. Subjects will be treated according to their routine clinical care and not dictated by the study. As the study is observational in nature, the study will collect data relating to the events specified above. Subjects that agree to this study will be followed-up for 5 years. Subject data will be collected every 3 months for the first 2 years and every 6 months for the last 3 years.

Conditions

Prostate Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

FIRMAGON

No interventions assigned to this group

GnRH Agonist

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Diagnosed with prostate cancer and indicated for androgen deprivation therapy (ADT)
• Decision made to prescribe ADT prior to enrolment
• Willing and able to provide written informed consent

Exclusion Criteria

• Participation in an interventional clinical study in which any treatment or follow-up is mandated
• Treatment with a GnRH receptor antagonist other than FIRMAGON
• Had previous or is currently under hormonal management of prostate cancer, except for subjects who have undergone therapy with curative intention where neoadjuvant/adjuvant therapy allowed for maximum 6 months. Treatment should be terminated at least 6 months prior to baseline.

• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Ferring Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Global Clinical Compliance

Role: STUDY_DIRECTOR

Ferring Pharmaceuticals

Locations

Onze-Lieve-Vrouwziekenhuis

Aalst, , Belgium

Ziekenhuisnetwerk Antwerpen - AZ Stuivenberg

Antwerp, , Belgium

AZ Sint-Jan AV

Bruges, , Belgium

Hôpitaux IRIS Sud

Brussels, , Belgium

Université Catholique de Louvain

Brussels, , Belgium

Hôpital Erasme

Bruxelle, , Belgium

AZ Sint-Blasius

Dendermonde, , Belgium

AZ Jan Palfijn

Ghent, , Belgium

AZ Maria Middelares

Ghent, , Belgium

AZ Sint-Lucas

Ghent, , Belgium

UZ Gent

Ghent, , Belgium

Regionaal Ziekenhuis Jan Yperman VZW

Ieper, , Belgium

AZ Groeninge - Campus Sint-Maarten

Kortrijk, , Belgium

CHU de Liège

Liège, , Belgium

Centre Hospitalier Universitaire Ambroise Paré

Mons, , Belgium

AZ Damiaan

Ostend, , Belgium

AZ-Sint-Elizabeth VZW

Zottegem, , Belgium

Aalborg Sygehus

Aalborg, , Denmark

Rigshospitalet

Copenhagen, , Denmark

Fredericia Hospital, Sygehus Lillebaelt

Fredericia, , Denmark

Herlev Hospital

Herlev, , Denmark

Holstebro Sygehus

Holstebro, , Denmark

Regionhospitalet Viborg

Viborg, , Denmark

Docrates clinic

Helsinki, , Finland

Pohjois-Karjalan keskussairaala

Joensuu, , Finland

Seinäjoen keskussairaala

Seinäjoki, , Finland

Tampereen yliopistollinen sairaala

Tampere, , Finland

Turun yliopistollinen keskussairaala

Turku, , Finland

Peijaksen sairaala

Vantaa, , Finland

CHRU Angers

Angers, , France

Centre Hospitalier d'Athis Mons site Caron

Athis-Mons, , France

Hopital Tenon

Aubervilliers, , France

Clinique Rhone Durance

Avignon, , France

CHU Saint-Jacques

Besançon, , France

Centre Hospitalier Laennec

Clermont-Ferrand, , France

Chu Gabriel Montpied

Clermont-Ferrand, , France

Ramsay Sante

Évry, , France

Groupement hospitalier Edouard Herriot

Lyon, , France

Cabinet Médical 65 prado

Marseille, , France

CHU Nord

Marseille, , France

Hopital de la Conception

Marseille, , France

Polyclinique Saint-Jean

Melun, , France

Clinique du Pont de Chaume

Montauban, , France

Clinique Beausoleil

Montpellier, , France

Centre d'Urologie de Nancy

Nancy, , France

Hôpital Max Fourestier

Nanterre, , France

Centre Hospitalier Georges Renon

Niort, , France

Groupe hospitalo-universitaire Caremeau

Nîmes, , France

Hopital Tenon

Paris, , France

Clinique du Ter

Ploemeur, , France

Clinic De L'Europe

Pontoise, , France

Hopital Pontchaillou

Rennes, , France

Clinique Saint Michel

Toulon, , France

Clinique St Jean Languedoc

Toulouse, , France

Hopital Bretonneau

Tours, , France

CHU Brabois

Vandœuvre-lès-Nancy, , France

Gemeinschaftspraxis Dres Effert und Benedic

Aachen, , Germany

Praxis Dr. Schlichter

Bad Bergzaben, , Germany

Praxis Dr. Markus Hentschel

Bautzen, , Germany

Praxis Dr. Richter

Bonn, , Germany

Urologie im Schlosscarree

Braunschweig, , Germany

Praxis Dr. Ahmad Haider

Bremerhaven, , Germany

Praxis Dr. Krieger

Chemnitz, , Germany

Urologie Chemnitz

Chemnitz, , Germany

Praxis Dr. Thomas Harms

Cologne, , Germany

Gemeinschaftspraxis fur Urologie

Dachau, , Germany

Klinikpraxis fur Urologie

Dinslaken, , Germany

Praxis Dr. Schönfelder

Hamburg, , Germany

Gemeinschaftspraxis Urologie

Kiel, , Germany

Urologische Gemeinschaftspraxis

Kiel, , Germany

Gemeinshaftspraxis Rudolph & Wörner

Kirchheim, , Germany

Vituro

Leipzig, , Germany

Praxis Alexander von Keitz

Marburg, , Germany

Praxis Dr. Peczat

Nienburg, , Germany

Studienzentrum München-Planegg

Planegg, , Germany

Urologische Gemeinschaftspraxis

Reutlingen, , Germany

Praxis Dr. Jan Franz

Tostedt, , Germany

Praxis fur Urologie

Wuppertal, , Germany

"Agios Savas" Anticancer-Oncology Hospital of Athens

Athens, , Greece

"G. Gennimtas" General Hospital of Athens

Athens, , Greece

"Laiko" General Hospital of Athens

Athens, , Greece

Amalia Fleming General Hospital of Athens

Athens, , Greece

Errikos Dynan Hospital of Athens

Athens, , Greece

Eurokliniki Hospital of Athens

Athens, , Greece

Evaggelismos General Hospital

Athens, , Greece

General Hospital of Athens "Ag. Olga" - Konstantopouleion

Athens, , Greece

Ippokrateio Hospital of Athens

Athens, , Greece

Korgialenio-Benakio

Athens, , Greece

Pe. Pa.G.N:I Hospital

Heraklion, , Greece

General hospital of Kalamata

Kalamata, , Greece

IASO General Hospital

Kalamata, , Greece

University Hospital of Larissa

Larissa, , Greece

Aghios Andreas General Hospital of Patras

Pátrai, , Greece

University General Hospital of Patras

Pátrai, , Greece

General Hospital of Piraeus "Tzanneio"

Piraeus, , Greece

"G. Gennimtas" General Hospital of Thessaloniki

Thessaloniki, , Greece

2nd IKA-ETAM "Panagia" General Hospital of Thessaloniki

Thessaloniki, , Greece

Papageorgiou General Hospital of Thessaloniki

Thessaloniki, , Greece

General Hospital of Volos "Achillopouleio"

Volos, , Greece

Azarka Zsuzsanna és Társa Bt

Budapest, , Hungary

UROFOR Bt

Debrecen, , Hungary

Kiskunhalasi Semmelweis Kórház Kht.

Kiskunhalas, , Hungary

Miskolci Semmelweis Ignác Egészségügyi Központ és Egyetemi Oktató Kórház Nonprofit Kft

Miskolc, , Hungary

Uro-Clin Kft

Pécs, , Hungary

FEjér Megyei Szent György Kórhaz

Székesfehérvár, , Hungary

Beacon Hospital

Dublin, , Ireland

Beaumont Hospital

Dublin, , Ireland

University College Hospital

Galway, , Ireland

Medical Consulting Center S.r.l.

Avellino, , Italy

Azienda Sanitaria Regionale del Molise (ASREM)

Campobasso, , Italy

Azienda Ospedaliera Mater Domini di Catanzaro

Catanzaro, , Italy

Azienda Ospedaliera Carlo Poma

Mantova, , Italy

Ospedale Luigi Sacco

Milan, , Italy

Azienda Ospedaliera Monaldi

Napoli, , Italy

Azienda Sanitaria Locale Salerno

Nocera Inferiore, , Italy

Ospedale Santa Maria delle Croci

Ravenna, , Italy

Azienda Ospedaliera "Bianchi-Melacrino-Morelli"

Reggio Calabria, , Italy

Istituto Nazionale Tumori "Regina Elena"

Roma, , Italy

Azienda Ospedaliera Universitaria OO.RR. S.Giovanni di Dio e Ruggi d'Aragona

Salerno, , Italy

ASL 4 di Teramo

Teramo, , Italy

Ospedale "San Pio da Pietrelcina"

Vasto, , Italy

AMC

Amsterdam, , Netherlands

Catharina ziekenhuis

Eindhoven, , Netherlands

Groene Hart Ziekenhuis

Gouda, , Netherlands

Diaconessenhuis Leiden

Leiden, , Netherlands

MC Haaglanden

The Hague, , Netherlands

Vestre Viken HF, Sykehuset Asker og Baerum

Asker, , Norway

Haukeland Universitetssykehus

Bergen, , Norway

Helse Nordmore og Romsdal HF, Kristiansund Sykehus

Kristiansund, , Norway

Olso Universitetssykehus HF, Radiumhospitalet

Oslo, , Norway

Oslo Universitetssykehus, Aker

Oslo, , Norway

Clinica de Santo Antonio

Lisbon, , Portugal

Hospital Militar

Lisbon, , Portugal

Hospital Santa Maria

Lisbon, , Portugal

VEBMED, s.r.o.

Bošany, , Slovakia

CUIMED, s.r.o.

Bratislava, , Slovakia

Nemocnica Svateho Michala, a.s.

Bratislava, , Slovakia

Univerzitna nemocnica Bratislava

Bratislava, , Slovakia

URO clinic, s.r.o.

Bratislava, , Slovakia

Poliklinika Galanta

Galanta, , Slovakia

MEDICONA s.r.o.

Košice, , Slovakia

UROCENTRUM LEVICE, s.r.o.

Levice, , Slovakia

Poliklinika Malacky

Malacky, , Slovakia

Univerzitna nemocnica Martin

Martin, , Slovakia

UROEXAM, spol. s r.o.

Nitra, , Slovakia

CENTRUM UROLOGIE Povazska Bystrica s.r.o

Považská Bystrica, , Slovakia

MILAB, s.r.o.

Prešov, , Slovakia

Nemocnica s poliklinikou Skalica, a.s.

Skalica, , Slovakia

UROCENTRUM SALA, s.r.o.

Šaľa, , Slovakia

M & M & M, s.r.o.

Topoľčany, , Slovakia

PRIVATNA UROLOGICKA AMBULANCIA s.r.o.

Trenčín, , Slovakia

UROREX, s.r.o.

Vráble, , Slovakia

Universitätsspital Basel

Basel, , Switzerland

Urozentrum Zürich

Zurich, , Switzerland

Homerton University Hospital

London, , United Kingdom

Kings College Hospital

London, , United Kingdom

Royal Marsden Hospital

London, , United Kingdom

Whipps Cross Hospital

London, , United Kingdom

East Surrey Hospital

Redhill, , United Kingdom

Sunderland Royal Hospital

Sunderland, , United Kingdom

Countries

Belgium; Denmark; Finland; France; Germany; Greece; Hungary; Ireland; Italy; Netherlands; Norway; Portugal; Slovakia; Switzerland; United Kingdom

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

FE200486 CS39

Identifier Type: -

Identifier Source: org_study_id